Effect of Platelet-rich Plasma (PRP) Injection on Knee Osteoarthritis

Sponsor

Xijing Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06082531

Collaborator

(none)

300

Enrollment

Location

Arms

Anticipated Duration (Months)

10.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the safety and effectiveness of PRP injection therapy in the repair of osteoarthritis and periarticular soft tissue injury through a single-center, exploratory clinical study, and to provide a more reliable basis for the treatment of joint injury.

Condition or Disease	Intervention/Treatment	Phase
Platelets-rich Plasma Osteoarthritis Knees Both Meniscus Disorder Cartilage Injury	Drug: Sodium hyaluronate injection	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Therapeutic Effect of Platelet-rich Plasma (PRP) Injection on Knee Osteoarthritis and Periarticular Tissue Injury

Actual Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Preoperative
Experimental: postoperative (6 weeks) The patients were injected with PRP.	Drug: Sodium hyaluronate injection The control group was injected into the joint cavity with sodium hyaluronate injection..
Experimental: postoperative (3 months) The patients were injected with PRP.	Drug: Sodium hyaluronate injection The control group was injected into the joint cavity with sodium hyaluronate injection..

Arm

Intervention/Treatment

No Intervention: Preoperative

Experimental: postoperative (6 weeks)

The patients were injected with PRP.

Drug: Sodium hyaluronate injection

The control group was injected into the joint cavity with sodium hyaluronate injection..

Experimental: postoperative (3 months)

The patients were injected with PRP.

Drug: Sodium hyaluronate injection

The control group was injected into the joint cavity with sodium hyaluronate injection..

Outcome Measures

Primary Outcome Measures

X-ray [pre-operation,3 weeks after treatment, 6 months after treatment]
The postoperative plain X-ray film was utilized for the assessment of knee joint deformity, stenosis of the joint space, and hyperplasia of osteophytes.
CT [pre-operation,3 weeks after treatment, 6 months after treatment]
The application of three-dimensional CT scan for the assessment of articular cartilage defects.
MRI [pre-operation,3 weeks after treatment, 6 months after treatment]
The injury of ligaments, meniscus, and the knee joint was assessed using MRI.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

The age range of the participants was 20 to 60 years old. Through a comprehensive clinical and imaging examination, it was conclusively determined that the individuals had knee osteoarthritis or experienced injuries to the cart, and meniscus surrounding the knee joint.
The preoperative routine tests and examinations revealed no contraindications.
Revised sentence: "Informed consent of the patient

Exclusion Criteria:

The platelet count or function exhibits significant abnormalities、Systemic infection transmitted through the bloodstream.
Prolonged usage of anti-inflammatory drugs and systemic corticoid administration.
In injection site or damage to the skin.
Patients with tumors or undergoing radiotherapy and chemotherapy.
Pregnant or breastfeeding women.
Individuals with mental illnesses who are unable to cooperate with follow-up procedures.
Contraindications for MRI、Patients or their families do consent to participate in the study.
Other circumstances that render participation in the study unsuitable.